Data / Medical devices / Intervertebral Fusion Device With Bone Graft, Lumbar / United States
FDA-registered makers of Intervertebral Fusion Device With Bone Graft, Lumbar in the United States: 241 establishments
241 establishments in the United States are registered with the FDA to make Intervertebral Fusion Device With Bone Graft, Lumbar (product code MAX). 87 have a 510(k) clearance or PMA approval on file and 24 have a recall event. FDA data exported November 2, 2026.
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- Device
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Product code
- MAX
- Country
- United States
Makers of Intervertebral Fusion Device With Bone Graft, Lumbar in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 49 | July 17, 2026 | 2 | 3 | 0 | api.fda.gov |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 44 | June 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 39 | June 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer, Repackager or relabeler | 38 | April 12, 2022 | 0 | 1 | 0 | api.fda.gov |
| Highridge Medical, LLC | Westminster, CO, United States | Manufacturer, Specification developer | 31 | May 21, 2025 | 2 | 4 | 0 | api.fda.gov |
| Life Spine | Huntley, IL, United States | Specification developer | 30 | July 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Seaspine Orthopedics Corporation | Carlsbad, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 28 | June 20, 2024 | 0 | 1 | 0 | api.fda.gov |
| Spinal Elements, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 28 | May 15, 2026 | 0 | 1 | 0 | api.fda.gov |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer | 21 | July 17, 2026 | 2 | 1 | 0 | api.fda.gov |
| Nuvasive, Inc. | Guaynabo, PR, United States | Manufacturer | 20 | June 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Depuy Spine, Inc. | Raynham, MA, United States | Complaint file establishment, Specification developer | 17 | March 8, 2023 | 1 | 2 | 0 | api.fda.gov |
| Alphatec Spine, Inc. | Carlsbad, CA, United States | Manufacturer, Specification developer | 16 | February 3, 2025 | 0 | 3 | 0 | api.fda.gov |
| Alphatec Spine, Inc. | Memphis, TN, United States | Manufacturer | 16 | February 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 16 | September 6, 2024 | 0 | 1 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Humacao | Humacao, PR, United States | Manufacturer | 16 | May 24, 2021 | 0 | 0 | 0 | api.fda.gov |
| Stryker Spine | Allendale, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 16 | July 25, 2019 | 0 | 5 | 0 | api.fda.gov |
| Zavation | Flowood, MS, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 16 | April 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Camber Spine Technologies | King of Prussia, PA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer | 14 | July 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Spine Wave, Inc. | Shelton, CT, United States | Manufacturer, Repackager or relabeler, Specification developer | 14 | May 29, 2026 | 0 | 1 | 0 | api.fda.gov |
| Choice Spine LLC | Knoxville, TN, United States | Complaint file establishment, Specification developer | 12 | September 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| CTL Medical Corporation | Carrollton, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 11 | October 10, 2024 | 0 | 1 | 0 | api.fda.gov |
| K2M, Inc. | Leesburg, VA, United States | Complaint file establishment, Manufacturer, Specification developer | 11 | December 14, 2017 | 0 | 1 | 0 | api.fda.gov |
| Orthofix Us LLC | Lewisville, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 11 | May 28, 2024 | 0 | 3 | 0 | api.fda.gov |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 11 | May 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Carlsmed, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 10 | July 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| 4web Inc. | Frisco, TX, United States | Specification developer | 9 | August 5, 2021 | 0 | 1 | 0 | api.fda.gov |
| Titan Spine, a Division of Medtronic | Milwaukee, WI, United States | Manufacturer | 9 | April 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Xtant Medical Holdings, Inc. | Belgrade, MT, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 9 | December 20, 2019 | 0 | 2 | 0 | api.fda.gov |
| Expanding Innovations, Inc. | Mountain View, CA, United States | Complaint file establishment, Manufacturer | 8 | June 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Astura Medical | Irving, TX, United States | Complaint file establishment, Specification developer | 7 | May 9, 2023 | 0 | 0 | 0 | api.fda.gov |
| INNO Holdings Inc. | Millcreek, UT, United States | Manufacturer | 7 | July 15, 2020 | 0 | 1 | 0 | api.fda.gov |
| Spineology Inc. | Saint Paul, MN, United States | Manufacturer | 7 | February 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| Genesys Spine | Austin, TX, United States | Manufacturer, Specification developer | 6 | March 9, 2022 | 0 | 1 | 0 | api.fda.gov |
| Altus Partners | West Chester, PA, United States | Repackager or relabeler, Specification developer | 5 | February 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Cutting Edge Spine | Mineral Spgs, NC, United States | Repackager or relabeler, Specification developer | 5 | May 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| Degen Medical | Florence, SC, United States | Complaint file establishment, Specification developer | 5 | April 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Kyocera Medical Technologies, Inc. | Redlands, CA, United States | Complaint file establishment, Specification developer | 5 | March 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Precision Spine, Inc. | Pearl, MS, United States | Manufacturer | 5 | December 8, 2021 | 0 | 0 | 0 | api.fda.gov |
| Acuity Surgical Devices, LLC | Irving, TX, United States | Manufacturer, Repackager or relabeler | 4 | June 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Adcura, Inc. | Wayzata, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | October 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| CAPTIVA SPINE, Inc. | Jupiter, FL, United States | Complaint file establishment, Specification developer | 4 | November 29, 2023 | 0 | 1 | 0 | api.fda.gov |
| Nexus Spine, L.L.C. | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 4 | March 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nexus Spine, LLC. | Lehi, UT, United States | Complaint file establishment, Specification developer | 4 | March 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nexxt Spine LLC | Noblesville, IN, United States | Complaint file establishment, Manufacturer | 4 | May 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Nvision Biomedical Technologies, Inc | San Antonio, TX, United States | Repackager or relabeler, Specification developer | 4 | September 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Vy Spine, LLC | Bountiful, UT, United States | Manufacturer, Specification developer | 4 | March 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Amplify Surgical | Foothill Ranch, CA, United States | Complaint file establishment, Specification developer | 3 | October 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Keos | Naples, FL, United States | Specification developer | 3 | December 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Mirus, LLC | Marietta, GA, United States | Manufacturer | 3 | August 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Nanovis Spine, LLC | Columbia City, IN, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | September 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Pantheon Spinal LLC | Georgetown, TX, United States | Complaint file establishment, Specification developer | 3 | December 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| SpineSmith Holdings, LLC | Austin, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 3 | March 29, 2017 | 0 | 0 | 0 | api.fda.gov |
| Curiteva, Inc. | Tanner, AL, United States | Contract manufacturer, Manufacturer | 2 | January 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Eminent Spine, LLC | Plano, TX, United States | Manufacturer | 2 | May 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Kalitec Direct LLC DBA Kalitec Medical | Sarasota, FL, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | May 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Met One Technologies, LLC | El Paso, TX, United States | Manufacturer, Specification developer | 2 | May 26, 2023 | 0 | 0 | 0 | api.fda.gov |
| NanoHive Medical LLC | Woburn, MA, United States | Manufacturer, Specification developer | 2 | July 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Omnia Medical | Morgantown, WV, United States | Specification developer | 2 | February 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Retropsoas Technologies, LLC | Frontenac, MO, United States | Complaint file establishment, Specification developer | 2 | October 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Teslake, Inc. | San Diego, CA, United States | Specification developer | 2 | April 23, 2015 | 0 | 0 | 0 | api.fda.gov |
| Wenzel Spine | Austin, TX, United States | Specification developer | 2 | January 28, 2019 | 0 | 0 | 0 | api.fda.gov |
| Xenco Medical LLC | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | August 24, 2018 | 0 | 0 | 0 | api.fda.gov |
| Xenix Medical | Orlando, FL, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | February 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Zsfab Inc | Waltham, MA, United States | Specification developer | 2 | November 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| restor3d, inc. | Durham, NC, United States | Complaint file establishment, Manufacturer | 2 | January 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Advanced Research Medical | Burnsville, MN, United States | Manufacturer | 1 | July 25, 2018 | 0 | 1 | 0 | api.fda.gov |
| Aurora Spine, Inc. | Carlsbad, CA, United States | Manufacturer, Specification developer | 1 | January 31, 2014 | 0 | 0 | 0 | api.fda.gov |
| Blustone Synergy, LLC | Pueblo, CO, United States | Specification developer | 1 | September 8, 2017 | 0 | 0 | 0 | api.fda.gov |
| Calvary Spine, LLC | Towson, MD, United States | Repackager or relabeler, Specification developer | 1 | October 17, 2008 | 0 | 0 | 0 | api.fda.gov |
| Elliquence LLC | Baldwin, NY, United States | Complaint file establishment, Specification developer | 1 | January 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Evolution Spine, LLC | Dallas, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | November 16, 2016 | 0 | 0 | 0 | api.fda.gov |
| Intelivation Technologies, LLC | Plymouth Meeting, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | October 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Integrity Spine | San Antonio, TX, United States | Manufacturer | 1 | November 10, 2015 | 0 | 0 | 0 | api.fda.gov |
| K7 LLC | Henderson, NV, United States | Manufacturer, Specification developer | 1 | December 9, 2013 | 0 | 0 | 0 | api.fda.gov |
| KL Distributing | Hudson, FL, United States | Manufacturer | 1 | February 1, 2018 | 0 | 0 | 0 | api.fda.gov |
| Ortho Development Corp. | Draper, UT, United States | Complaint file establishment, Manufacturer | 1 | October 25, 2011 | 0 | 0 | 0 | api.fda.gov |
| Orthocircle | Savannah, GA, United States | Specification developer | 1 | October 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| Osseus Fusion Systems LLC | Dallas, TX, United States | Repackager or relabeler, Specification developer | 1 | August 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| Republic Spine | Fort Lauderdale, FL, United States | Complaint file establishment, Manufacturer | 1 | September 12, 2019 | 0 | 0 | 0 | api.fda.gov |
| Romd, LLC | Rochester Hills, MI, United States | Contract manufacturer, Manufacturer | 1 | April 21, 2011 | 0 | 0 | 0 | api.fda.gov |
| Southern Spine, LLC | Macon, GA, United States | Specification developer | 1 | November 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Spine Innovation, LLC | Coronado, CA, United States | Complaint file establishment, Specification developer | 1 | January 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| SPINEFRONTIER, INC. DBA LESspine Innovations | Burlington, MA, United States | Manufacturer | 1 | June 19, 2020 | 0 | 2 | 0 | api.fda.gov |
| Surgtech, Inc. | Westlake, OH, United States | Manufacturer, Specification developer | 1 | March 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| Spinal Surgical Strategies, Inc | Incline Village, NV, United States | Specification developer | 1 | September 14, 2021 | 0 | 0 | 0 | api.fda.gov |
| Thompson Mis | Sandown, NH, United States | Specification developer | 1 | October 26, 2011 | 0 | 0 | 0 | api.fda.gov |
| Valorus Spine, LLC | Danville, CA, United States | Manufacturer | 1 | October 25, 2017 | 0 | 0 | 0 | api.fda.gov |
| Alden Tool Company, Inc. | Berlin, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Manufacturing And Engineering | Montgomeryville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aps Materials, Inc. | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ar Fabricating | Georgetown, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH - Quakertown | Quakertown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arch Medical Solutions - Philadelphia, LLC Dba Jade Precision Medical Components | Huntingdon Valley, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Elmhurst | Elmhurst, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Olive Branch | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Seabrook | Seabrook, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Warsaw | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Integrated Medical Solutions, Inc | Mentor, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AVALIGN TECHNOLOGIES, Inc. | Fort Wayne, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Axial Medical | Ivyland, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acero Precision | West Chester, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Additive / Slice Manufacturing Studios | Akron, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Delivery Systems Division | Greenwood, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B & G MFG. Co. | Hatfield, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B & J Medical LLC | Kendallville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Banister Tool, Inc. | Pflugerville, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biogennix, LLC | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biopro, Inc. | Port Huron, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boulder Biomed LLC | Boulder, CO, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Branch Medical Group | Eagleville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Branch Medical Group | Limerick, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bradshaw Medical Inc. | Kenosha, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C&A Tool Engineering, Inc. Auburn Plant | Auburn, IN, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| C&W Swiss, Inc. | Clayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C+a Tool Engineering, Inc. | Churubusco, IN, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Complexus Medical | Mishawaka, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Orthopaedics, Inc. | Raynham, MA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Design And Services Hub, LLC | Hartville, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Donson Machine Company | Alsip, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam Plastics, Ltd | Northfield, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical, LLC | Florence, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical, LLC | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Oakland, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| First Article Inc | Souderton, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flex-Cell Precision, Inc. | Lancaster, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foundation Surgical Group | Scottsdale, AZ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Little Ferry, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G Surgical LLC | Austin, TX, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gauthier Biomedical, Inc. | Grafton, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Geotec, Inc. | Warwick, RI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guardian Medical Usa, Inc | Swanton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harwood Design, Inc. | Bristol, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HC Biologics LLC | Miami, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hoosier, Inc. | Corona, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Insert Molding Solutions, Inc. | Cumming, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isotis Orthobiologics, Inc | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J & J Precision Technologies, LLC | Lititz, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J&B Precision, Inc. | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jarvis Surgical Inc. | Westfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jatex, Inc. | Nappanee, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jewel Precision Sheet Metal & Machining, Inc. | Cedar Grove, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Brandywine) | W Chester, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Elmira) | Horseheads, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LH Medical Corporation | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linear Precision, Inc. | Florence, SC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LISI MEDICAL REmmele | Big Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LISI MEDICAL Remmele | Coon Rapids, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lincotek Medical | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lincotek Medical LLC | Vandalia, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mackay Manufacturing, Inc. | Spokane Valley, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mainstream Medical Devices | Austin, TX, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maitland Engineering | South Bend, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Device And Implants LLC | Lancaster, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Modeling - A 3D Systems Company | Littleton, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtech LLC | Millington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Navigation, Inc. | Lafayette, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Precision Swiss | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micropulse Inc | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Machining Midtown LLC | Atlanta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Grand Rapids | Grand Rapids, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medynus, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mendell | Lakeville, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metal Craft Machine & Engineering, Inc. | Elk River, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microcision LLC | Pennsauken, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ngage Medical Manufacturing | Hernando, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NML Medical, LLC | West Carrollton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novapproach Spine, LLC | Alachua, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NextPhase Medical Devices LLC | Rochester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Healthcare Baja Inc. (Albuquerque) | Albuquerque, NM, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Odyssey Medical Technologies, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osteomni Inc | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedic Solutions Alabama LLC | Arab, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pacific Instruments Inc. | Honolulu, HI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Packaging Compliance Medical, LLC | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perryman Company | Houston, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Edge Surgical Products Company | Sault Sainte Marie, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Medical Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro Surgical, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Solutions, LLC | Brunswick, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulse Technologies, Inc. | Quakertown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Dayton | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Smithfield, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phillips Precision Inc | Elmwood Park, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pioneer Surgical Technology, Inc. | Marquette, MI, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Precision Medical Technologies- North Manchester Manufacturing Facility | N Manchester, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R.K. Manufacturing | Danbury, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverside Machine & Engineering, Inc. | Eau Claire, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMS Co. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RSB Spine LLC. | Wooster, OH, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SINTX Technologies Inc. | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spinecraft LLC | Westmont, IL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stoll Metalcraft, Inc. | Santa Clarita, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Naples, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Instrument Manufacturers, LLC | Fenton, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical, Inc. - Manchester | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sites Medical, LLC | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Mooresville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Orthopaedic Implant Company | Reno, NV, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TOMZ Corporation | Berlin, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Troy Innovative Instruments Co LLC | Middlefield, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turnco Tool & Instrument, Inc. | Georgetown, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turner Medical Inc. | Athens, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tangible Solutions, Inc. DBA Marle Tangible, Inc. | Fairborn, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tech Industries. Inc. | Cleveland, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tegra Medical | Hernando, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The E F PRECISION GROUP | Willow Grove, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tyber Medical | Bethlehem, PA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tyber Medical | Bethlehem, PA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unity Tool, Inc. | Osseo, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Victoria Precision Inc. | Trevose, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex) | Parkrose, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vorzeigen | Connersville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Medical, LLC | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westwood Precision LLC | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wheelhouse Medical | Monroe, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Watershed Idea Foundry, Inc. | Carlsbad, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xyresic LLC | Jackson, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zigg Design LLC | Nibley, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer Trabecular Metal Technology, Inc. | Parsippany, NJ, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 1 | 0 | api.fda.gov | |
| rms Surgical | Anoka, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.